EUCTR2020-000664-31-SE进行中（未招募）1 期
A Registry-based, Randomised, Double-blind, Placebo-ControlledCardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on Cardiometabolic Outcomes in Patients without Diabetes with Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure - DAPA-MI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant must be =18 at the time of signing the informed consent.
- •2 Confirmed MI, either STEMI or NSTEMI, according to the fourth
- •universal definition of MI (Thygesen et al 2019), within the preceding 7
- •days, or 10 days if earlier randomisation is not feasible.
- •3. Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation (established with
- •echocardiogram, radionuclide ventriculogram, contrast angiography or
- •cardiac MRI) OR definitive evidence on ECG of Q wave MI (defined as
- •presence of Q waves in 2 or more contiguous leads, excluding leads III
- •and aVR, and meeting all the following criteria: at least 1.5mm in depth;
- •at least 30 ms in duration; and, if R wave present, more than 25% of the
- •size of the subsequent R wave).
- •4. Haemodynamically stable at randomisation (no episodes of
- •symptomatic hypotension, or arrhythmia with haemodynamic
- •compromise in the last 24 hours).
- •5. Male or female
- •6. Capable of giving signed informed consent which includes compliance
- •with the requirements and restrictions listed in the informed consent
- •form (ICF) and in the protocol
- •7. Provision of signed and dated, written informed consent prior to any
- •mandatory study specific procedures, sampling, and analyses.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1750
排除标准
- •1. Known T1DM or T2DM at the time for admission. Patients with
- •hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the
- •index event, are eligible at the discretion of the Investigator. Patients
- •who present with signs and symptoms consistent with ketoacidosis,
- •including nausea, vomiting, abdominal pain, malaise and shortness of
- •breath should be assessed for ketoacidosis, and if ketoacidosis is
- •confirmed the patient should not be randomized.
- •2. Chronic symptomatic HF with a prior HHF within the last year and
- •known reduced ejection fraction (LVEF=40 %), documented before the
- •current MI hospitalization.
- •3. Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or
- •rapidly progressing renal disease at the time of randomization.
- •4. Severe hepatic impairment (Child-Pugh class C) at the time of
- •inclusion into the trial.
- •5. Active malignancy requiring treatment at the time of screening,
- •except for basal cell- or squamous cell carcinoma of the skin, presumed
- •possible to treat successfully.
- •6. Any non-CV condition, eg malignancy, with a life expectancy of less
- •than two years based on the investigator´s clinical judgement.
- •7. Currently on treatment, or with an indication for treatment, with a
- •SGLT2-inhibitor.
- •8. Known intolerance to dapagliflozin
- •9. Participation in another study with a non-approved investigational
- •drug or blinded treatment with a CV or glucose lowering medication.
- •10. Involvement in the planning and/or conduct of the study (applies to
- •AZ staff, UCR staff and/or staff at the study site).
- •11. Judgement by the investigator that the participant should not
- •participate in the study if the participant is unlikely to comply with study
- •procedures, restrictions and requirements, or any condition in the
- •opinion of the Investigator that would make participation unsafe or
- •unsuitable.
- •12. Previous randomisation in the present study.
- •13. Women of childbearing potential (ie, those who are not chemically
- •or surgically sterilised or postmenopausal):
- •(a) Who are not willing to use a highly effective method of
- •contraception (described below), OR
- •(b) Who have a positive pregnancy test, OR
- •(c) Who are breast-feeding.
研究者
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